HOUSTON – Vincent Dammai, 42, of Pleasant, S.C., has entered a guilty plea to causing the introduction of stem cells into interstate commerce without the approval of the Food and Drug Administration (FDA), United States Attorney Kenneth Magidson announced today.

Dammai was a former assistant professor of Pathology and Laboratory Medicine at the Medical University of South Carolina. The superseding criminal information charged him with introducing stem cells processed at the university into interstate commerce without FDA approval. Dammai entered the guilty plea yesterday before U.S. Magistrate Judge Frances Stacey.

The charges against Dammai was the result of an investigation by the FDA and the FBI into the manufacture, distribution, sale and use of stem cells in the treatment of human autoimmune diseases. Currently, the FDA has not approved the use of stem cells for the treatment of diseases such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS) and Parkinson’s disease.

During the investigation, agents discovered that co-conspirator Francisco Morales falsely represented to the public that he was a physician licensed to practice medicine in the United States and had experience in performing stem cell procedures for the treatment of ALS, MS and Parkinson’s. Agents further discovered Morales obtained stem cells from Fredda Branyon, the owner of a company called Global Laboratories located in Scottsdale, Ariz.

While trying to determine the source of the stem cells sold to Morales by Global Laboratories, agents discovered that Dammai was processing stem cells at the Medical University in South Carolina without university or FDA approval.

During the plea, Dammai admitted that beginning in 2006 while employed with the university, he used university facilities to harvest and process stem cells for a company called Caledonia Consulting located in South Carolina. He further admitted he harvested stem cells for Caledonia from March 2006 through December 2008 and was paid approximately $161,625. Dammai acknowledged he was only authorized to conduct research for kidney cancer and was not permitted to harvest or process stem cells.

Dammai also admitted that in late December 2008, Caledonia Consulting was sold to Branyon and that Caledonia was then dissolved. Branyon then established a company named Global Laboratories. Dammai admitted that in May 2009 he entered into a consulting agreement with Branyon to provide guidance to Global Laboratories regarding the processing of stem cells. As a result of this agreement, Dammai routinely received umbilical cord blood in South Carolina from Global Laboratories and processed stem cells from the cord blood at the Medical University. Dammai would then send the stem cells he processed to Global Laboratories in Arizona. However, Dammai did not have any formal training in how to process stem cells.

Dammai admitted he received more than $55,00 from Global Laboratories for processing the stem cells. The stem cells were later sold by Branyon to Francisco Morales.

Sentencing has been set for Nov. 14, 2013, at which time Dammai faces up to one year in prison and a $10,000 fine.

Branyon and Morales have also entered guilty pleas in relation to the case and are also pending sentencing.

Assistant United States Attorneys Samuel Louis and Cedric Joubert prosecuted the case.